Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device bed, pediatric open hospital
Product CodeFMS
Regulation Number 880.5140
Device Class 2

MDR Year MDR Reports MDR Events
2014 157 157
2015 175 175
2016 137 137
2017 121 121
2018 113 113
2019 30 103
2020 28 139
2021 28 91
2022 22 91
2023 29 130
2024 5 32

Device Problems MDRs with this Device Problem Events in those MDRs
Break 194 194
Device Slipped 169 169
Device Operates Differently Than Expected 117 117
Mechanical Problem 50 50
Positioning Failure 46 349
Sticking 45 45
Device Fell 35 84
False Reading From Device Non-Compliance 30 30
Incorrect Measurement 26 70
Detachment Of Device Component 25 25
Loose or Intermittent Connection 23 23
Component Falling 22 22
Incorrect, Inadequate or Imprecise Result or Readings 17 17
Unintended Movement 17 17
Mechanics Altered 16 16
Positioning Problem 16 61
Scratched Material 15 15
Improper Device Output 13 13
Failure to Disconnect 13 13
Device Displays Incorrect Message 13 13
Naturally Worn 11 11
Mechanical Jam 11 12
Component Missing 10 10
Failure to Align 9 9
Unintended System Motion 9 9
Failure to Zero 9 9
Malposition of Device 8 8
Insufficient Information 8 8
Device Inoperable 7 7
Calibration Problem 6 6
Patient Device Interaction Problem 6 7
Defective Component 5 5
Output Problem 5 5
Material Integrity Problem 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Connection Problem 4 4
Unstable 4 4
Material Separation 4 4
Crack 4 4
Material Frayed 4 4
Disconnection 3 3
Bent 3 3
Delamination 3 3
Defective Device 3 3
Incorrect Or Inadequate Test Results 3 3
Human-Device Interface Problem 3 3
Sharp Edges 3 3
Device Dislodged or Dislocated 2 4
Detachment of Device or Device Component 2 2
Protective Measures Problem 2 2
Failure to Calibrate 2 2
Structural Problem 2 2
Battery Problem 2 2
Collapse 2 2
Peeled/Delaminated 2 2
Difficult To Position 2 2
Product Quality Problem 1 1
Failure to Recalibrate 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Misconnection 1 1
Use of Device Problem 1 1
Metal Shedding Debris 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Signal Artifact/Noise 1 1
Difficult or Delayed Positioning 1 1
Entrapment of Device 1 1
False Device Output 1 1
Imprecision 1 1
Device Tipped Over 1 1
Activation, Positioning or Separation Problem 1 1
Computer Operating System Problem 1 1
Low Battery 1 1
Cut In Material 1 1
High Readings 1 1
Low Readings 1 1
Measurement System Incompatibility 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Open or Close 1 1
Fail-Safe Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Physical Resistance/Sticking 1 1
Appropriate Term/Code Not Available 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 534 534
No Consequences Or Impact To Patient 138 138
No Clinical Signs, Symptoms or Conditions 85 370
No Patient Involvement 52 220
Physical Entrapment 9 10
Fall 8 8
Insufficient Information 6 6
Injury 5 5
No Information 4 4
Bruise/Contusion 4 4
Swelling 3 3
Laceration(s) 2 2
Abrasion 2 3
Bone Fracture(s) 1 1
Head Injury 1 1
Pain 1 2
Concussion 1 1
Vertebral Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 PediaLift LLC II Feb-02-2020
2 Stryker Medical Division of Stryker Corporation II Aug-06-2021
-
-